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Pivotal phase 3 study of Alpha-1 antitrypsin in the patients with Alpha-1 Antitrypsin Deficiency (AATD).

Trial Profile

Pivotal phase 3 study of Alpha-1 antitrypsin in the patients with Alpha-1 Antitrypsin Deficiency (AATD).

Planning
Phase of Trial: Phase III

Latest Information Update: 10 Jul 2018

At a glance

  • Drugs Alpha 1-antitrypsin (Primary) ; Alpha 1-antitrypsin
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors Kamada
  • Most Recent Events

    • 10 Jul 2018 According to a Kamada media release, company has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the development plan for this study.
    • 23 Apr 2018 According to Kamada media release, the company received feedback from the U.S. Food and Drug Administration (FDA) regarding the proposed pivotal Phase 3 protocol for Alpha-1 Antitrypsin for treatment of Alpha-1 Antitrypsin Deficiency. The company has formally requested, and is expecting to present planned Phase 3 protocol in a Scientific Advice meeting with the European Medicines Agency in the third quarter of 2018.
    • 13 Nov 2017 Kamada expects a response from the FDA in regards to the proposed protocol and will submit additional data at the beginning of 2018.
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